Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children
NCT ID: NCT06137560
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
210 participants
INTERVENTIONAL
2023-12-22
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children
NCT05243836
The P.A.U.S.E.® Spectacle Study
NCT06577948
Influence of Rodenstock Spectacle Lenses on Myopia Progression.
NCT06816446
A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children
NCT06860737
Stellest Lenses and Low-concentration Atropine Myopia Control Among Children
NCT06344429
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In the second part of this trial, participants will be randomly allocated wear of of two spectacle lens options (the best performer from S.T.O.P.® Kits 1 and 2 in terms of reducing the rate of myopic progression and single vision spectacle lenses + S.T.O.P.® film). As previously stated, both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue while S.T.O.P.® film provide a static optical cue.
The overall trial duration, including follow-up period, is expected to be approximately 42 months. Each participant's duration is expected to be approximately 30 months.
The visits are Baseline, Dispensing, 1 month, 4 months, 6 months, then visits every 6 months after.
All procedures performed at these visits are standard, non invasive clinical tests.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Assigned Intervention 1
Single vision spectacle lens
Single vision spectacle lens
Standard single vision spectacle lens
Assigned Intervention 2
Single vision spectacle lens + S.T.O.P.® Kit 1
Single vision spectacle lens + S.T.O.P.® Kit 1
Standard single vision spectacle lens + S.T.O.P.® Kit 1
Assigned Intervention 3
Single vision spectacle lens + S.T.O.P.® Kit 2
Single vision spectacle lens + S.T.O.P.® Kit 2
Standard single vision spectacle lens + S.T.O.P.® Kit 2
Assigned Intervention 4
Static optical signal: single vision spectacle lens + S.T.O.P.® spectacle film
Single vision spectacle lens + S.T.O.P.® Film
Standard single vision spectacle lens + S.T.O.P.® Film
Assigned Intervention 5
Dynamic optical signal: single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Single vision spectacle lens
Standard single vision spectacle lens
Single vision spectacle lens + S.T.O.P.® Kit 1
Standard single vision spectacle lens + S.T.O.P.® Kit 1
Single vision spectacle lens + S.T.O.P.® Kit 2
Standard single vision spectacle lens + S.T.O.P.® Kit 2
Single vision spectacle lens + S.T.O.P.® Film
Standard single vision spectacle lens + S.T.O.P.® Film
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have:
* Read the Informed Assent.
* Been explained the Informed Assent.
* Indicated an understanding of the Informed Assent.
* Signed the Informed Assent.
* Have their parent / legal guardian:
* Read the Informed Consent.
* Been explained the Informed Consent.
* Indicated an understanding of the Informed Consent.
* Signed the Informed Consent.
* Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
* Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
* Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
* Possess wearable and visually functioning spectacles.
* Be in good general health, based on the parent's / legal guardian's knowledge.
* Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
* Meet the following criteria determined by cycloplegic autorefraction at Baseline:
* -5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS.
* -1.50 DC ≤ astigmatic component ≤ 0 DC.
* \|Spherical equivalent anisometropia\| ≤ 1.00 D.
Exclusion Criteria
* Current or prior use of ANY form of myopia control, including but not limited to:
* Optical devices:
* Bifocal or multifocal spectacles of any type.
* Bifocal or multifocal contact lenses of any type.
* Orthokeratology of any type.
* Pharmacological agents:
* Atropine with a concentration \> 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
* Pirenzepine
* Participant born earlier than 30 weeks or weighed \< 1500 g at birth.
* A verbal report from the participant's parent / legal guardian is sufficient.
* Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
* A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
* Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
* Known ocular or systemic disease, such as but not limited to:
* Diabetes.
* Graves' disease.
* Glaucoma.
* Uveitis.
* Scleritis.
* Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
* Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
* Persistent pupillary membrane.
* Vitreous haemorrhage.
* Cataract.
* Central corneal scarring.
* Eyelid haemangiomas.
* Marfan's syndrome.
* Down's syndrome.
* Ehler's-Danlos syndrome.
* Stickler's syndrome.
* Ocular albinism.
* Retinopathy of prematurity.
* Keratoconus or irregular cornea.
* The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.
6 Years
14 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.
UNKNOWN
nthalmic Pty Ltd
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniel Tilia, MOptom, PhD
Principal Research Optometrist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Tilia, Optom, PhD
Role: PRINCIPAL_INVESTIGATOR
nthalmic Pty Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tianjin Eye Hospital
Tianjin, Heping District, China
Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, China
Divyajyoti Trust Tejas Eye Hospital
Surat, Gujarat, India
LV Prasad Eye Institute
Hyderabad, Telangana, India
Pristine Eye Hospitals
Hyderabad, Telangana, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
nthal2021-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.